Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification (LOBACOM)

July 12, 2023 updated by: University Hospital, Brest
  • Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
  • The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
  • This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
  • The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
  • The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

  • Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
  • The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
  • This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
  • The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement control impairment". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
  • The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.

LoBaCoM is a monocentric, exploratory prospective study.

The purpose is to define a kinematic (angular) threshold corresponding to an anomaly detected clinically by three therapists for each test.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Finistère
      • Brest, Finistère, France, 29609
        • Recruiting
        • CHU de Brest
        • Contact:
        • Sub-Investigator:
          • Marine BOURHIS
        • Sub-Investigator:
          • Fanny GARGADENNEC
        • Sub-Investigator:
          • Thimothée HOUGRON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged more than 18 years
  • Common low back pain with medical prescription for rehabilitation
  • Signed consent
  • Be affiliated to a social security scheme
  • Be able to perform the lumbar motion control failure tests

Exclusion Criteria:

  • Body Mass Index greater than 30 (obesity)
  • Person who does not understand French
  • Pregnant woman
  • Refusal to participate
  • Volunteer under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: motion control fault testing

Each patient make six motion control fault tests in the same order :

  1. "waiters bow"
  2. "pelvic tilt"
  3. "one leg stance"
  4. "sitting knee extension"
  5. "rocking 4 point kneeling"
  6. "prone knee bend"

This tests are performed three times.

Patients make 6 motion control fault tests, in the same order. Each test is performed three times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of compensation motion : "waiters bow" test
Time Frame: Day 0
Lumbar flexion measured for test number 1 "waiters bow". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Day 0
Range of compensation motion : "pelvic tilt" test
Time Frame: Day 0
thoracic flexion measured for test number 2 "pelvic tilt". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Day 0
Range of compensation motion : "One leg stance" test
Time Frame: Day 0
Pelvic shift measured for test number 3 "One leg stance ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Day 0
Range of compensation motion : "sitting knee extension" test
Time Frame: Day 0
Lumbar flexion measured for test number 4 "sitting knee extension". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Day 0
Range of compensation motion : "rocking 4 point kneeling" test
Time Frame: Day 0
Lumbar flexion and extension measured for test number 5 "rocking 4 point kneeling ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Day 0
Range of compensation motion : "prone knee bend" test
Time Frame: Day 0
Lumbar extension measured for test number 6 "prone knee bend". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of execution for test 1
Time Frame: Day 0
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Day 0
Speed of execution for test 2
Time Frame: Day 0
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Day 0
Speed of execution for test 3
Time Frame: Day 0
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Day 0
Speed of execution for test 4
Time Frame: Day 0
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Day 0
Speed of execution for test 5
Time Frame: Day 0
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Day 0
Speed of execution for test 6
Time Frame: Day 0
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC22.0128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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